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NCT07520422
Bacillus Coagulans Based Product in IBS-Diarrhea
NA trial testing Probiotic Arm in IBS-D (Diarrhea-predominant) in 50 participants. Completed in 25 May 2023.
25 May 2023
Quick facts
| Lead sponsor | Bioagile Therapeutics Pvt. Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 25 February 2023 |
| Primary completion | 25 May 2023 |
| Estimated completion | 25 May 2023 |
| Sites | 1 location across India |
Drugs / interventions tested
- Probiotic Arm — full drug profile →
- Placebo
Conditions studied
- IBS-D (Diarrhea-predominant) — all drugs for IBS-D (Diarrhea-predominant) →
Sponsor
Bioagile Therapeutics Pvt. Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with IBS-D (Diarrhea-predominant). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, randomized, double-blind, placebo-controlled, parallel-group interventional clinical trial designed to evaluate the efficacy and safety of a Bacillus coagulans-based product in adult patients with mild to moderate Irritable Bowel Syndrome with predominant diarrhea (IBS-D), diagnosed according to Rome III criteria. A total of 50 eligible male and female participants aged 18 to 65 years will be randomized in a 1:1 ratio to receive either Bacillus coagulans capsules or matching placebo for 8 weeks. The investigational product contains Bacillus coagulans (10⁶-10⁸ CFU) administered orally twice daily, morning and evening. The primary objective is to assess the effect of the study product on IBS-D symptoms, including abdominal pain, gastrointestinal symptom severity, stool consistency, and stool frequency, using validated assessment tools such as Abdominal Pain Visual Analogue Scale (VAS), IBS Symptom Severity Scale (IBS-SSS), and Bristol Stool Form Scale (BSFS). Secondary assessments include changes in hematological parameters and lipid profile biomarkers, along with safety monitoring through vital signs and adverse event reporting. Participants will attend four study visits: screening, baseline, Week 4, and Week 8. Weekly symptom recordings for abdominal pain and stool characteristics will be documented using participant diary cards throughout the treatment period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07520422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Probiotic Arm
Trials testing the same drug.
- NCT07253155 — Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity. · NA · enrolling by invitation
- NCT07504952 — Investigating the Impact of Probiotics on Wellbeing in a Community · NA · completed
- NCT06910397 — The Effect of Probiotics on Gums Health and Bad Breath · NA · completed
Other recruiting trials for IBS-D (Diarrhea-predominant)
Currently open trials in the same condition.
- NCT07168434 — Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome · Phase 3 · recruiting
Other Bioagile Therapeutics Pvt. Ltd. trials
Trials by the same sponsor.
- NCT07378033 — Body Fat Reduction and Weight Management · NA · enrolling by invitation
- NCT07377942 — To Evaluate the Effect of Bacillus Subtilis Based Product in Gut Health and Immunomodulatory Effect in Healthy Adults. · NA · enrolling by invitation
- NCT07377994 — To Evaluate the Effect of Bacillus Coagulans Based Product in Gut Health and Immunomodulatory Effect in Healthy Adults · NA · enrolling by invitation
- NCT07452744 — Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease · NA · enrolling by invitation
- NCT07452757 — To Evaluate Efficacy and Safety of Proprietary Healthy Diet Combinations for Weight Management in Overweight Volunteers · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07520422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bioagile Therapeutics Pvt. Ltd.
- Last refreshed: 9 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07520422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing